Ketek Side Effects

Note: This page contains information about the side effects of telithromycin. Some of the dosage forms included on this document may not apply to the brand name Ketek.

In Summary

Common side effects of Ketek include: diarrhea. Other side effects include: headache and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to telithromycin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by telithromycin (the active ingredient contained in Ketek). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking telithromycin:

Rare

Abdominal or stomach pain

blistering, peeling, or loosening of the skin

blurred vision

chest pain or discomfort

chills

confusion

convulsions

cough

dark urine

decreased urine

difficulty with breathing, chewing, swallowing, or talking

dizziness

double vision

drooping eyelids

dry mouth

fainting

faintness or lightheadedness when getting up suddenly from a lying or sitting position

Minor Side Effects

Some of the side effects that can occur with telithromycin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

For Healthcare Professionals

Applies to telithromycin: oral tablet

Hepatic

Severe liver injury and acute liver failure (in some cases fatal) have been reported. Such hepatic reactions were observed during or immediately after therapy and included fulminant hepatitis and hepatic necrosis leading to liver transplant. In some cases, liver injury progressed rapidly and occurred after a few doses of this drug were administered. Less severe liver dysfunction (associated with reversible hepatitis, elevated liver enzymes, and sometimes jaundice) has been reported.

Drug-related hepatotoxicity was reported in a 46-year-old man receiving treatment for an ear and sinus infection. The patient presented with a 4-day history of malaise, dark urine, jaundice, mild pruritus, and anorexia. The patient denied toxin exposure, IV drug abuse, or hepatic injury. ALT 948 units/L, AST 200 units/L, total bilirubin 65 mmol/L, and alkaline phosphatase 291 units/L were observed. These values warranted withdrawal of this drug and within 2 weeks the ALT decreased to 450 units/L and his jaundice resolved. After 8 weeks, the patient's liver tests had normalized.[Ref]

Pseudomembranous colitis has also been reported during postmarketing experience.[Ref]

Nervous system

Exacerbations of myasthenia gravis (including fatal and life-threatening acute respiratory failure) have been reported. Rapid onset was observed in some cases, occurring within a few hours after the first dose.[Ref]

Ventricular arrhythmias (including ventricular tachycardia, torsades de pointes) have sometimes occurred within a few hours after the first dose.

Atrial arrhythmias and palpitation have also been reported during postmarketing experience.[Ref]

Ocular

Visual disturbances (some severe) most often included blurred vision, difficulty focusing, or diplopia; some patients stopped therapy due to these effects. Most visual side effects were reported after the first or second dose, lasted several hours, and recurred with subsequent doses in some patients. Symptoms continued throughout the entire course of therapy in some patients and resolved spontaneously during therapy in others. Females and patients up to 40 years of age had a higher rate of these side effects (females up to 40 years: 2.1%; females older than 40 years: 1%; males up to 40 years: 1.2%; males older than 40 years: 0.27%).[Ref]

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